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Regulatory Affairs Manager

Job Information
LocationRecruitment Agency / Vacancy in SA. South Africa
SalaryR950k- R550k
Job TypePermanent
EducationDoctorate degree, Master’s degree or Bachelor’s degree
Experience5 - 7 Years
Referencezve
Emailpharmacy.jobs(at)hireresolve.co.za
Fax0867502763

Job Description

Regulatory Affairs Manager

A Leading company in Biotechnology is giving you the opportunity to become a part of their amazing team of specialists.

Requirements

Doctorate degree, Master’s degree or Bachelor’s degree

5 - 7 years of related experience

Responsibilities

• Ensures the elaboration of high quality DRD (Marketing Authorization Application, Product variation, etc.) to obtain first pass approval in compliance with regulatory requirements.

Participates in key decision making involved in drug registration dossier elaboration.

• Ensures the updating of the registration file according to local regulations during the product life-cycle.

• Coordinates the preparation and execution of New Molecules Committee meetings.

• Participates in site Inspection visits escorting and serving as contact point between officials and site employees.

• Reviews, evaluates and authorizes changes controls related to generation and update texts for package and package insert.

• Coordinates translations of regulatory documents and dossiers

• Evaluates the impact of new regulation on the internal process and coordinates the implementation of regulatory changes

• Keeps updated legal-regulatory documentation CPP, GMPs, LoA, etc.

• Maintain professional relationships with appropriate health authorities based on science and technical expertise

• Provides regulatory and compliance knowledge to cross functional teams and keep updated on regulations and their changes.

• Supports Global Safety Area in regulatory activities related with Safety Reporting.

Should you meet the requirements for this position, please email your CV to pharmacy.jobs@hireresolve.co.za or fax to 086 571 7307 or alternatively call on 021 551 8638.

Correspondence will only be conducted with short listed candidates. Should you not hear from us within 3 days, please consider your application unsuccessful.

Hire Resolve offers a R1000 for any candidate that I referred and placed through Hire Resolve. Hire Resolve also offers a R1000 job spec fee for any referral that results in a placement through Hire Resolve. If your company is looking for any IT, Finance and Engineering staff, please email us at jobspec@hiresresolve.co.za with the company name, a contact person and contact email or number of the person doing the hiring. We will keep the referral strictly confidential.



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